Easily establish structure of biosimilar drugs

In the US, biopharmaceutical innovators have 12 years of patent protection for biologic medicines, at which point it becomes possible for biosimilar and biobetter sponsors to market similar therapeutic protein products.

The FDA has published the scientific consideration for demonstrating biosimilarity to a reference product, which provides insight how they will evaluate biosimilar biological products. In order to establish the biosimilarity of a therapeutic drug candidate to the original innovator molecule, both proteins must be exhaustively structurally characterized for a number of criteria—all covered in International Council for Harmonization guidelines ICH Q5E and ICH Q6B.

A key step to proving biosimilarity is to establish glycosylation patterns, because variations in glycosylation can affect the efficacy and safety of therapeutic proteins, influencing their biological activity, serum half-life, and immunogenicity. Monosaccharides, including sialic acid composition analysis can detect variations in glycosylation, and support quality control for process development and manufacturing procedures. As a result, proteins are routinely analyzed to determine their monosaccharides and sialic acids amount and identity.

Featured videos

BioPharma Charge Variant & Aggregate Analysis eBook

As biopharmaceutical development expands, so too does the need for analytical techniques that address key challenges of throughput and robustness. Get this new eBook and learn how to overcome these challenges with novel ion exchange (IEC) and size exclusion (SEC) chromatography workflows.